Catalog Number CS-25703-E |
Device Problem
Fitting Problem (2183)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Associated mdr#'s: 3006425876-2022-00935.
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Event Description
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It was reported during the first insertion, the junction between the ars (arrow raulerson syringe) and introducer needle "loosed easily".The same situation happened again during the second insertion.The third time the insertion succeeded.It was reported the device was replaced and there was no delay in therapy or patient complications.No medical intervention was required.Additional information received 29sep2022 that the patient was deceased."the patient was in critical condition prior to use the devices.The patient death was not caused by complaint devices." additional information was requested, but was not available at the time of this report.
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Manufacturer Narrative
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(b)(4).Associated mdr#'s 3006425876-2022-00936 and 3006425876-2022-00935.The customer returned one, opened cvc kit for analysis.The ars and 18 ga introducer needle will be analyzed as part of this investigation.Signs of use were observed on the needle hub.Visual inspection did not reveal any defects or anomalies.There were no cracks observed in the needle hub.The ars tip appeared normal.The connection between the returned syringe and needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.The returned needle appears to be fitting loosely on both the returned syringe and the lab inventory syringe.The hub of the needle was tested with the male luer gauge and was not within the specified range.This indicates that the luer was nonconforming per iso 594-1:1986.The ars and needle involved with this complaint was sent to the wyomissing facility for additional testing and ftir & swm/eds analysis.Ftir & swm/eds analysis revealed a build-up of silicone lubricant on the surface of the ars tip and the needle hub.Further discussions between r & d and manufacturing revealed that the silicone application process is a mechanical setup based on visual criteria.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The report of a syringe/needle connection issue was confirmed through complaint investigation.Visual analysis did not reveal any obvious defects or anomalies; however, functional testing revealed that the connection was loose.The sample was sent to r & d for additional analysis.They discovered a build-up of silicone on the ars tip and needle hub surfaces, which is not intended and likely occurred during manufacturing.Based on the customer report and the comments from r & d, the root cause cannot be determined and warrants further evaluation.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported during the first insertion, the junction between the ars (arrow raulerson syringe) and introducer needle "loosed easily".The same situation happened again during the second insertion.The third time the insertion succeeded.It was reported the device was replaced and there was no delay in therapy or patient complications.No medical intervention was required.Additional information received 29sep2022 that the patient was deceased."the patient was in critical condition prior to use the devices.The patient death was not caused by complaint devices." additional information was requested, but was not available at the time of this report.
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Manufacturer Narrative
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(b)(4).Associated mdr#'s 3006425876-2022-00936 and 3006425876-2022-00935.Investigation results: the customer returned one, opened cvc kit for analysis.The ars and 18 ga introducer needle will be analyzed as part of this investigation.Signs of use were observed on the needle hub.Visual inspection did not reveal any defects or anomalies.There were no cracks observed in the needle hub.The ars tip appeared normal.The connection between the returned syringe and needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.The returned needle appears to be fitting loosely on both the returned syringe and the lab inventory syringe.The hub of the needle was tested with the male luer gauge and was within the specified range.This indicates that the luer was conforming per iso 80369-7.The ars and needle involved with this complaint was sent to the wyomissing facility for additional testing and ftir & swm/eds analysis.Ftir & swm/eds analysis revealed a build-up of silicone lubricant on the surface of the ars tip and the needle hub.Further discussions between r & d and manufacturing revealed that the silicone application process is a mechanical setup based on visual criteria.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The report of a syringe/needle connection issue was confirmed through complaint investigation.Visual analysis did not reveal any obvious defects or anomalies; however, functional testing revealed that the connection was loose.The sample was sent to r & d for additional analysis.They discovered a build-up of silicone on the ars tip and needle hub surfaces, which is not intended and likely occurred during manufacturing.Based on the customer report and the comments from r & d, the root cause cannot be determined and warrants further evaluation.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported during the first insertion, the junction between the ars (arrow raulerson syringe) and introducer needle "loosed easily".The same situation happened again during the second insertion.The third time the insertion succeeded.It was reported the device was replaced and there was no delay in therapy or patient complications.No medical intervention was required.Additional information received on 29sep2022 that the patient was deceased."the patient was in critical condition prior to use the devices.The patient death was not caused by complaint devices." additional information was requested, but was not available at the time of this report.
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Search Alerts/Recalls
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